Successful OPAL BROADEN Phase III trial for Xeljanz (tofacitinib) to treat Psoriatic Arthritis- Pfizer

Pfizer Inc. announced top-line results from its first Phase III study investigating tofacitinib for the treatment of psoriatic arthritis, Oral Psoriatic Arthritis triaL (OPAL) BROADEN. This study evaluated the efficacy and safety of tofacitinib 5 mg and 10 mg twice daily (BID) in adult patients with active psoriatic arthritis (PsA) who had an inadequate response to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) and who were tumor necrosis factor inhibitor (TNFi)-naïve.

OPAL BROADEN met its primary efficacy endpoints demonstrating that both tofacitinib 5 mg BID and 10 mg BID were superior to treatment with placebo at 3 months as measured by American College of Rheumatology 20 (ACR20) response and Health Assessment Questionnaire Disability Index (HAQ-DI) score. OPAL BROADEN is a Phase III placebo-controlled study that investigated the efficacy and safety of tofacitinib 5 mg and 10 mg BID in treating the signs and symptoms of PsA, and improvement in physical function in patients with active PsA who had an inadequate response to at least one csDMARD ( conventional synthetic disease-modifying antirheumatic drug ) due to lack of efficacy or adverse event, and who were TNFi-naive. Patients enrolled in the study were required to be on one csDMARD as background therapy and continue that dose for the duration of the study. The study also included adalimumab 40 mg subcutaneously administered every 2 weeks (q2 wk) as an active control arm. However, this study was not powered for non-inferiority or superiority comparisons between tofacitinib and adalimumab. A total of 422 patients were randomized in a 2:2:2:1:1 ratio to the following treatment arms: tofacitinib 5 mg BID, tofacitinib 10 mg BID, adalimumab 40 mg q2 wk, placebo to tofacitinib 5 mg BID and placebo to tofacitinib 10 mg BID treatment sequences. Overall safety findings in this study were consistent with those observed in the broader rheumatology clinical development program for tofacitinib. All treatment groups had similar rates of treatment-emergent adverse events, serious adverse events, and discontinuations due to adverse events over the 12-month duration of the study. Serious adverse events observed were similar to those seen in other clinical development programs for tofacitinib.

Comment: By the second half of 2016, Pfizer expects data from OPAL BEYOND, another Phase III study of Xeljanz to treat psoriatic arthritis. The company hopes to use data from OPAL BROADEN, OPAL BEYOND, and the OPAL BALANCE extension trial in regulatory applications to add psoriatic arthritis to the Xeljanz label.